Amino Acid Tracer (FACBC) Positron Emission Tomography fo... | NCT01502670

Studies
Amino Acid Tracer (FACBC) Positron Emission Tomography for Lung Nodule

NCT01502670

Sponsor

Emory University

Status

Completed

Last Update Posted

Nov 19, 2013Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Lung Cancer

Interventions

18F-FACBC Radiotracer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
14701	Other Identifier	Other

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jun 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Dec 21, 2011

First Submission Date that Met QC Criteria

Dec 30, 2011

First Posted Date

Jan 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2013

Last Update Posted Date

Nov 19, 2013Estimated

Name	Class
Nihon Medi-Physics Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will look at how the [18]FACBC goes into the lung nodules. This will hopefully lead to the development of better imaging techniques to look at lung nodules. [18]FACBC is not approved by the FDA (Food and Drug Administration). This study will help to determine if it should be approved by the FDA.

Detailed Description

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to tumor cells, as has been shown in the detection and staging of prostate cancer and for brain tumors. In this study we are going to test this new substance in patients with lung nodules. Lung nodules are a common finding. It is very important to non-invasively determine whether the nodule is cancer or not, as early cancer detection and treatment may cure the disease. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the lung nodules, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance often goes to inflammatory tissues as well. This new substance does not significantly go to inflammatory tissues, and may allow tumors in the lungs to be better identified.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung Nodule	Experimental		Drug: 18F-FACBC Radiotracer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FACBC Radiotracer	Drug	Test radiotracer uptake in lung nodule	Lung Nodule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of Radiotracer Uptake with Histology	We will correlate radiotracer uptake with histology results	Typically 1-2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be 18 years of age or older.
Patients with a history of cancer who have a solitary pulmonary nodule between 1-3 cm in short axis with clinical and CT characteristics warranting surgical removal (see below).
Clinical, laboratory, or diagnostic imaging findings on CT or 18F-FDG PET-CT do not suggest the possibility of the SPN being part of a metastatic process.
Ability to lie still for PET scanning
Patients must be able to provide written informed consent.

Exclusion Criteria:

Age less than 18.
Active carcinoma with known metastatic disease.
Size of primary lesion less than 1 cm or greater than 3 cm
Not a candidate for surgical resection or biopsy based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy.
Inability to lie still for PET scanning
Cannot provide written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Emory University		Atlanta	Georgia	30322	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23595643	Result	Amzat R, Taleghani P, Miller DL, Beitler JJ, Bellamy LM, Nye JA, Yu W, Savir-Baruch B, Osunkoya AO, Chen Z, Auffermann WF, Goodman MM, Schuster DM. Pilot study of the utility of the synthetic PET amino-acid radiotracer anti-1-amino-3-[(18)F]fluorocyclobutane-1-carboxylic acid for the noninvasive imaging of pulmonary lesions. Mol Imaging Biol. 2013 Oct;15(5):633-43. doi: 10.1007/s11307-012-0606-7.

ID	Term
D008175	Lung Neoplasms
D055613	Multiple Pulmonary Nodules

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms